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Completed

NCT Number: NCT01415830

Compare Two Anti-Scorpion Venom Serum In Children

The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.

On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).

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Key information

Conditions

Scorpion Sting Bites and Stings Chemically-Induced Disorders Poisoning Scorpion Stings Wounds and Injuries

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital General Regional de León

León, Guanajuato, 37320, Mexico

About this study

We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scorpion sting
  • Either sex
  • Age 1 to 15 years
  • Signing an informed consent (signed by parent or guardian)
  • Being residents of the state of Guanajuato

Exclusion criteria

  • Previous treatment with gamma globulin or immunoglobulin
  • Blood transfusion at any stage of life
  • Patients treated with drugs that interact with anti-scorpion serum
  • History or history of sensitivity or intolerance to anti-scorpion serum or horse products
  • Pregnancy
  • Any immunodeficiency
  • Patients who have participated in a research protocol in the previous month.

Treatment and study plan

Anti-scorpion venom serum Birmex

Biological

the dose may be required for the patient according to clinical manifestations and evolution

Other names: anti-scorpion venom serum

Anti-scorpion venom serum Alacramyn

Biological

The dose may be required fot the patient according to clinical manifestations and evolution

Other names: antiscorpion venom serum

Primary outcomes

  1. Resolution of signs and symptoms of scorpion envenomation

    Time frame: after treatment (expected average of 12 hrs)

Secondary outcomes

  1. Evaluate the adverse events in every treated child

    Time frame: inmediately after treatment and until 5 days later

Sponsors and collaborators

Lead sponsor

Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Other

Registry information

Official study title

Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 12, 2011
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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